510(k) K230443
K230443 is an FDA 510(k) premarket notification submitted by Jiangxi Royall Smart Technology Co., Ltd. for the device "TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)". The FDA issued a decision of Substantially Equivalent on May 22, 2023. The device falls under product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter), a Class II device regulated under 21 CFR 882.5890.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 22, 2023
- Date Received
- Feb 21, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Nerve, Transcutaneous, Over-The-Counter
- Device Class
- Class II
- Regulation Number
- 882.5890
- Review Panel
- NE
- Submission Type
- 510(k)
TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES